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External Controls In Clinical Research (Part I) The Clinical Imperative

To help shed light on data collection and analysis issues for external controls, this paper examines what constitutes external controls and considers. ....

Michaelf Murphy , Williaml Slone , Clinical Research Methodology , Assistant Director , Chief Medical And Scientific ,

Ensuring Access And Approval For Innovative Therapies In Scleroderma

Clinical research and development programs for innovative therapies in scleroderma must accommodate the diverse data needs of multiple stakeholders. ....

Andrew Kuhlman , Michaelf Murphy , Melissa Vadnais , Clinical Research Methodology , Chief Medical And Scientific Officer ,

COVID-19 Vaccine Development Building On A Legacy Of Innovation

COVID-19 Vaccine Development Building On A Legacy Of Innovation
clinicalleader.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from clinicalleader.com Daily Mail and Mail on Sunday newspapers.

Erinm Griner , Andrew Kuhlman , Michaelf Murphy , Williaml Slone , Melissa Vadnais , Clinical Research Methodology , Assistant Director , Clinical Trial Methodology Fellow , Medical Writer , Chief Medical , ஆண்ட்ரூ குல்மான் , மெலிசா வத்ணைச் , மருத்துவ ஆராய்ச்சி முறை , உதவியாளர் இயக்குனர் , மருத்துவ சோதனை முறை சக , மருத்துவ எழுத்தாளர் , தலைமை மருத்துவ ,

External Controls (Part II) Informed Choices Amidst A Portfolio Of Options

External Controls (Part II): Informed Choices Amidst A Portfolio Of Options
William L. Slone, Ph.D., Assistant Director, Clinical Research Methodology; Melissa Vadnais, VMD, Ph. D., Clinical Trial Methodology Fellow; Andrew Kuhlman, Medical Writer; Michael F. Murphy, MD, Ph. D., Chief Medical & Scientific Officer
As discussed in Part 1 of this series (EXTERNAL CONTROLS IN CLINICAL RESEARCH (PART I): THE CLINICAL IMPERATIVE), regulatory concepts referable to the creation of an external control group have long been noted and occasionally implemented, particularly for diseases with severe morbidity, mortality, and unmet medical need. As defined in Guidance for Industry: E10 Choice of Control Group and Related Issues in Clinical Trials (2001), “an externally controlled trial is one in which the control group consists of patients who are not part of the same randomized study as the group receiving the investigational agent.” ....

Andrew Kuhlman , Williaml Slone , Michaelf Murphy , Melissa Vadnais , Choice Of Control Group , Clinical Research Methodology , Group Doctors Tablet , Assistant Director , Clinical Trial Methodology Fellow , Medical Writer , Chief Medical , Control Group , Related Issues , Clinical Trials , ஆண்ட்ரூ குல்மான் , மெலிசா வத்ணைச் , தேர்வு ஆஃப் கட்டுப்பாடு குழு , மருத்துவ ஆராய்ச்சி முறை , குழு மருத்துவர்கள் டேப்லெட் , உதவியாளர் இயக்குனர் , மருத்துவ சோதனை முறை சக , மருத்துவ எழுத்தாளர் , தலைமை மருத்துவ , கட்டுப்பாடு குழு , தொடர்புடையது சிக்கல்கள் , மருத்துவ சோதனைகள் ,